EXPAN

19-2-2019

Chukar Cherries Expands Recall Of Amaretto Rainier Ultra Dark Chocolate Cherries Pouches Due To Undeclared Milk

February 18, 2019, Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Ultra Dark Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

13-2-2019

Ottogi America, Inc. Expands Recall on Undeclared Egg in Products

Ottogi America, Inc. announced today it is expanding its recall to include the two items below due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

SL: Recall of Thrive Market Nut Butters Due to Potential Health Risk

Thrive Market, Inc, is recalling all unexpired lots of the Thrive Market-branded nut butters listed below (“Product(s)”) due to the potential for contamination with Listeria monocytogenes. On January 21, 2019, one of our suppliers notified us that it was issuing a recall of all nut butters it has manufactured since January 2018 because of a positive test for Listeria monocytogenes in recent lots. Because the safety of our members is our absolute priority, we are expanding on our supplier’s recall and a...

FDA - U.S. Food and Drug Administration

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

15-1-2019

Expanded recall: Shermag recalls Harrison convertible 4 in 1 crib

The hardware on the cribs can become loose and detach, allowing the sides of the crib to widen, creating a hazardous gap in which infants and toddlers can become wedged or entrapped, posing risks of suffocation and strangulation.Hardware failures can also lead to the crib to collapse as sides may detach.

Health Canada

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

26-12-2018

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls

Apio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail ...

FDA - U.S. Food and Drug Administration

24-12-2018

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes

FDA - U.S. Food and Drug Administration

13-12-2018

Expanded Recall: TJX Canada recalls Various Casa Décor Brand Glass Knobs

The drawer knobs can shatter when pulled, posing a laceration hazard.

Health Canada

6-12-2018

Expanded Recall: Skip Hop expands recall on Tuo Convertible High Chairs

The front legs on the highchair can detach from the seat, posing a fall and injury hazard to children.

Health Canada

5-12-2018

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk

Chukar Cherries of Prosser, WA expands a recall on Ultra Dark Chocolate product because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

9-11-2018

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D

We regret to inform you that Natural Life® Chicken & Potato dry dog food has been confirmed to contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

8-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

5-10-2018

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

18-8-2018

Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution

August 18, 2018

Health Canada

12-7-2018

FDA expands its support for states to advance implementation of produce safety activities

FDA expands its support for states to advance implementation of produce safety activities

FDA - U.S. Food and Drug Administration

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

6-7-2018

Expanded Recall: Peg Perego Canada Inc. recalls Various Book Strollers

Health Canada's sampling and evaluation program has determined that these strollers do not meet the Carriages and Strollers Regulations in Canada. Specifically, the strollers do not meet the latching system requirements for folding strollers as they do not have a safety device independent of the latching device to prevent folding.

Health Canada

14-6-2018

ANSES consolidates its presence in Boulogne-sur-Mer!

Centrally located in the port of Boulogne-sur-Mer, the Laboratory for Food Safety's site specialising in fishery and aquaculture products is expanding! This extension, financed jointly by the Hauts-de-France Region and the local community, underlines ANSES's scientific investment in Boulogne-sur-Mer and is fully consistent with regional research dynamics for the quality and safety of aquatic products.

France - Agence Nationale du Médicament Vétérinaire

12-6-2018

FLIR Lorex, Inc. recalls certain Lorex Video Monitors

Batteries in the affected monitors can overheat and expand, posing a potential burn hazard to consumers.

Health Canada

1-6-2018

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

The recalled products may be contaminated with the bacteria Burkolderia cepacia. Burkolderia cepacia can pose a risk of infections to consumers, especially those with weakened immune systems. Contamination of the bacteria has only been confirmed for the Remedy Essentials Cleanser No Rinse Foam that was includedin the previous recall.

Health Canada

30-5-2018

FDA approves new treatment for moderately to severely active ulcerative colitis

FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

FDA - U.S. Food and Drug Administration

29-5-2018

Expanded Recall: Stroller Boutique recalls Anex Sport stroller

Health Canada’s sampling and evaluation program has determined these strollers do not meet the Carriages and Strollers Regulations in Canada. Specifically, the strollers contain barium in excess of allowable limits. Additionally, these strollers do not meet Health Canada's stability requirements. These strollers may tip-over while in use, posing a fall hazard.

Health Canada

28-5-2018

Expanded Recall: Various Uncertified USB Chargers Recalled due to Fire and Shock Risk

The recalled USB chargers did not pass a standard electrical test, and may pose a risk of electrical shock and fire.

Health Canada

11-5-2018

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

FDA - U.S. Food and Drug Administration

2-5-2018

Human medicines European public assessment report (EPAR): Velphoro, mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches, Revision: 5, Authorised

Europe - EMA - European Medicines Agency

20-4-2018

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk.

FDA - U.S. Food and Drug Administration

18-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Active substance: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells) - Transfer of orphan designation - Commission Decision (2019)1375 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003671

Europe -DG Health and Food Safety

23-1-2019

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

17-1-2019

Holoclar (Chiesi Farmaceutici S.p.A.)

Holoclar (Active substance: Ex vivo expanded autologous human corneal epithelial cells containing stem cells) - Centralised - Annual renewal - Commission Decision (2019)272 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2450/R/21

Europe -DG Health and Food Safety

15-1-2019

EU/3/17/1852 (Voisin Consulting S.A.R.L.)

EU/3/17/1852 (Active substance: Allogeneic ex-vivo-expanded umbilical cord blood-derived hematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived hematopoietic mature myeloid and lymphoid cells) - Transfer of orphan designation - Commission Decision (2019)233 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002948

Europe -DG Health and Food Safety

11-1-2019

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Europe - EMA - European Medicines Agency

19-12-2018

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Europe - EMA - European Medicines Agency

18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019

Therapeutic Goods Administration - Australia

12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Europe - EMA - European Medicines Agency

12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

22-11-2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Europe - EMA - European Medicines Agency

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

21-10-2018

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed h

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed health decisions.

FDA - U.S. Food and Drug Administration

5-9-2018

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical devices

FDA - U.S. Food and Drug Administration

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (Active substance: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded) - Orphan designation - Commission Decision (2018)5276 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/18

Europe -DG Health and Food Safety

22-7-2018

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial equivalence.

FDA - U.S. Food and Drug Administration

19-7-2018

HES (hydroxyethyl starch)

HES (hydroxyethyl starch) (Active substance: hydroxyethyl starch (HES), solutions for infusion) - Community Referrals - Art 107i - Commission Decision (2018)4832 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-107i/1457

Europe -DG Health and Food Safety

22-6-2018

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ  pic.twitter.com/wZdrU6tTzf

FDA - U.S. Food and Drug Administration

16-5-2018

EU/3/09/667 (Takeda Pharma A/S)

EU/3/09/667 (Active substance: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue) - Transfer of orphan designation - Commission Decision (2018)3029 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/054/09/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Active substance: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist) - Transfer of orphan designation - Commission Decision (2018)3044 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/120/14/T/01

Europe -DG Health and Food Safety

17-4-2018

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Active substance: Autologous skeletal myoblasts expanded ex vivo) - Refusal of orphan designation - Commission Decision (2018)2354 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/144/17

Europe -DG Health and Food Safety